Many women have been angry to discover that they paid thousands of dollars for ineffective fertility shots. Women in the United States and Canada were exposed to harm by the fertility drug Bravelle®, including losing the chance for a potential pregnancy, overstimulation or hyperstimulation of ovaries, heart problems and other serious side effects. Litster Frost Injury Lawyers is evaluating these cases and accepting Bravelle clients nationwide.
What is Bravelle?
Bravelle is a prescription fertility drug produced by the company Ferring Pharmaceuticals to treat certain fertility problems in women. The drug is a purified form of a follicle stimulating hormone (urofollitropin) used to aid in the maturing of the eggs for ovulation.
Bravelle (urofollitropin injection) is a drug that was approved in 2002 to treat female infertility. Swiss manufacturer Ferring Pharmaceuticals advertised that treatments could begin a woman’s “baby story.” The drug is a highly purified form of human follicle-stimulating hormone (FSH) that can stimulate egg maturation and increase the potential for pregnancy.
Unfortunately, batches of Bravelle failed to meet the 24 month shelf-life guarantee and the company began recalling Bravelle in 2015.
In September 2015 Ferring Pharmaceuticals quietly initiated a Class 3 recall with the Food and Drug Administration. The recall was not announced to the public. Class 3 recalls are not safety recalls likely to cause adverse health consequences. They do not obligate manufacturers, the FDA or medical providers to notify consumers. However; some pharmacies and clinics did notify patients of the recall. In October 2015 a company spokesperson announced that the company was temporarily pulling Bravelle from shelves because some batches of the drug sold in 2014 “did not meet potency specifications for their full 24 month shelf life.” Tests showed that the drug’s potency decreased at a more rapid rate than stated by the manufacturer, resulting in ineffective treatments and lack of expected results.
However, the company’s September 2015 report to the FDA indicated that the drug failed to meet even a 12 month shelf life. The FDA listed Bravelle as a “Subpotent Drug: Stability samples were confirmed to be out of specification for potency at the 12 month time point” (See FDA Enforcement Report for week of October 21, 2015.)
Have you been harmed by Bravelle?
Bravelle has had a severe negative impact on the lives of disappointed or injured users. Women are learning that the expensive, painful injections they received were virtually worthless and that windows of time and opportunity have been squandered. Many have gone into debt for the high cost of Bravelle treatments, which can cost over $100 a day for many months. As if the financial burden weren’t enough, increasing dosages given over an extended period of time may increase the chance of risky side effects and limit future fertility treatments to more expensive, invasive options. Bravelle side effects can include:
- Loss of chance of potential pregnancy
- Overstimulation of ovaries (OHSS; Ovarian Hyperstimulation Syndrome)
- Multiple births
- Heart problems